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Comparison of Microbiota and Quality of Life for a Low FODMAPs and Standard Dietary in Irritable Bowel Syndrome Patients

Sponsor
Jinsong Wang (Other)
Overall Status
Unknown status
CT.gov ID
NCT02902926
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
5.9
Duration (Months)
20.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Low FODMAPs Diet
  • Behavioral: Diet instruction
 N/A

Detailed Description

IBS is a global disease, patients often because of long-term symptoms of recurrent, not timely diagnosis and treatment effect is not ideal and frequent treatment, seriously affect the quality of life, and cause the corresponding economic and social burden.At present，a number of studies suggest that fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAPs) can induce IBS symptoms.Data from large randomized controlled trials are limited, leaving clinicians with the challenge of providing patients with reliable guidance based on minimal evidence.

This study will compare the effect of low FODMAPs diet and usual diet instruction on Intestinal flora, intestinal short chain fatty acids and quality of life by two groups.The results will answer the effect and long-term safety of Low FODMAPs diet.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Microbiota and Quality of Life for a Low FODMAPs Versus Standard Dietary Advice in Patients With Irritable Bowel Syndrome
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low FODMAPs Diet

Instructed to low FODMAPs diet when patients signed the informed consent. Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.

Behavioral: Low FODMAPs Diet
Instruct to design and eat Low Fermentable，Oligo-，Di-，Mono-saccharides And Polyols(FODMAPs) Diet

Behavioral: Diet instruction
Answer the doubt and help the patient get the diet knowlege about the IBS.
Placebo Comparator: Diet Instruction

1.Answer doubts and correct unhealthy dietary behaviors,such as excessive diet, eating raw, spirits and other excitant food.

Behavioral: Diet instruction
Answer the doubt and help the patient get the diet knowlege about the IBS.

Outcome Measures

Primary Outcome Measures

  1. Microbiota / Short chain fatty acids [Change from baseline Microbiota / Short chain fatty acids at 4 weeks]

    The fecal samples of IBS patients were analyzed.

Secondary Outcome Measures

  1. Irritable bowel syndrome severity scoring system scale [Baseline,1,and 3 month post randomization]

    Irritable bowel syndrome severity scoring system scale is an integral system for monitoring the severity of IBS in patients with disease severity.The scale is mainly from the degree of abdominal pain, abdominal pain frequency, abdominal distension, defecation satisfaction and the impact of life, according to the 10cm visual scoring method

  2. The Short Form 36 (SF-36) scale [Baseline,1,and 3 month post randomization]

    SF-36 is a general scale, at present, the most commonly used evaluation of IBS. It includes 36 items, a total of 8 dimensions

  3. Irritable bowel syndrome quality of life (IBS-QOL) scale [Baseline,1,and 3 month post randomization]

    Irritable bowel syndrome quality of life (IBS-QOL) scale is a more extensive application of the specific scale of IBS.

  4. Satisfaction questionnaire [1,and 3 month post randomization]

    To understand the patient's satisfaction with symptom control and diet guidance. The questionnaire included 3 items

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnostic criteria for Rome Ⅲ

  • IBS patients with diarrhea type

  • By endoscopy, X-ray, B ultrasound and laboratory examination to exclude organic disease

  • Patients be able to communicate well with the researchers and be willing to participate in the study

Exclusion Criteria:

  • Stomach, small intestine, colon surgery history

  • irritable bowel disease (IBD) active period, celiac disease

  • Alcoholics or drug abuse

  • Pregnant or lactating women

  • Recent drug users who use defecation

  • Have a special diet

Contacts and Locations

Locations

Site City State Country Postal Code
1 YangzhouUniversity Yangzhou Jiangsu China 225001

Sponsors and Collaborators

  • Jinsong Wang

Investigators

  • Study Chair: Hongcan Shi, Ph.D.,M.D., Medical College

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Jinsong Wang, Director of Center for Clincal Epidemiology, Yangzhou University
ClinicalTrials.gov Identifier:
NCT02902926
Other Study ID Numbers:
  • 20160805
First Posted:
Sep 16, 2016
Last Update Posted:
Sep 16, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Irritable Bowel Syndrome

Study Results

No Results Posted as of Sep 16, 2016